Dural Medical Adhesive for Watertight Sealing in Dural Repair
4 de agosto de 2026 atualizado por: Medprin Regenerative Medical Technologies Co., Ltd.
A Multicenter, Single-blind, Randomized Controlled Clinical Trial on the Safety and Effectiveness of Dural Medical Adhesive for Watertight Sealing in Dural Repair
This is a prospective, multicenter, single-blind, randomized controlled superiority clinical trial of dural medical adhesive for watertight sealing after primary spinal dural repair to prevent cerebrospinal fluid (CSF) leakage.
A total of 141 patients with intraoperative CSF leakage after primary dural repair from 7 medical centers will be enrolled at a 2:1 randomization ratio (94 in adhesive group, 47 in standard treatment control group).
Intraoperative watertight sealing success rate is the primary outcome.
Postoperative CSF leakage rate at day 10±5 and day 90±7, drainage volume/duration, and adverse events/serious adverse events within 90 days are secondary outcomes to evaluate the safety and effectiveness of the investigational device.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
The investigational product is dural medical adhesive indicated for watertight sealing of dural defects in spinal surgery to prevent CSF leakage. This superiority trial adopts a prospective, multicenter, single-blind, randomized controlled design with 7 participating neurosurgical centers across China. Eligible patients are adults with visible CSF leakage after one-layer primary dural repair confirmed by intraoperative visualization, Valsalva maneuver or hemostatic sponge test. Subjects are randomly assigned 2:1 via sealed envelopes to two groups.
Intervention group: standard primary dural repair + dural medical adhesive evenly coated on the repair site for instant watertight sealing; a second application is allowed if persistent leakage occurs after first use.
Control group: standard treatment including autologous fat/fascia/muscle graft or reinforced suture after primary repair without medical adhesive.
All participants receive follow-up at postoperative day 10±5 (Visit 1) and day 90±7 (Visit 2). Primary efficacy endpoint is intraoperative successful watertight sealing without CSF leakage. Secondary endpoints include postoperative CSF leakage incidence at two time points, postoperative drainage volume and indwelling duration, and overall safety profiles including all adverse events and serious adverse events within 90 days post-operation. Statistical analyses will be performed on Full Analysis Set (FAS) and Per Protocol Set (PPS) for efficacy, and Safety Set (SS) for safety evaluation.
Tipo de estudo
Intervencional
Inscrição (Real)
141
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Beijing, China
- Peking University Third Hospital
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Beijing, China
- Xuanwu Hospital, Capital Medical University
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Guangzhou, China
- Nanfang Hospital, Southern Medical University
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Nanchang, China
- The First Affiliated Hospital of Nanchang University
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Shenzhen, China
- Shenzhen Second People's Hospital
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Xi'an, China
- Xi'an Honghui Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Aged 18-75 years old, any gender.
- Undergoing spinal surgery with dural incision, traumatic tear or defect requiring primary repair.
- Intraoperative confirmed CSF leakage after primary dural repair via naked eye, microscopy, Valsalva maneuver or hemostatic sponge test.
- Patient or legal guardian voluntarily signs written informed consent form.
Exclusion Criteria:
- Participated in another interventional clinical trial within 1 month before surgery.
- Severe cardiac, hepatic, renal or hematological disease unable to tolerate spinal surgery.
- Known hypersensitivity to any component of dural medical adhesive (polyethylenimine, 4-arm PEG succinimidyl glutarate, brilliant blue, ε-poly-L-lysine hydrochloride).
- History of severe anaphylaxis or immunodeficiency disorders.
- Expected survival less than 3 months post-operation.
- Pregnant, lactating female or women planning pregnancy within 3 months after surgery.
- Poor treatment compliance judged by investigator, unable to complete full follow-up visits.
- Unable to understand trial information and cooperate with assessment.
- Intraoperative dural defect that cannot receive primary sutured repair.
- Class III contaminated surgical wound or active infection at operation site.
- Any other condition judged inappropriate for trial participation by investigator.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Dural Medical Adhesive Treatment Group
After routine primary suture repair of spinal dural defects and intraoperative confirmation of cerebrospinal fluid leakage, evenly apply the investigational dural medical adhesive to the sutured repair area.
After the adhesive is fully cured, perform Valsalva maneuver / hemostatic sponge test to recheck watertight sealing status.
One additional application of the adhesive is permitted if leakage persists after the first application.
Postoperative routine drainage and standardized follow-up are implemented.
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After primary suture repair of spinal dural defect with intraoperative confirmed cerebrospinal fluid leakage, evenly coat the adhesive over the sutured area.
After curing, use Valsalva maneuver or hemostatic sponge test to check sealing effect.
One repeated application is permitted if leakage persists.
Postoperative drainage and unified follow-up schedule are performed.
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Comparador Ativo: Standard Conventional Treatment Control Group
After routine primary suture repair of spinal dural defects with confirmed intraoperative cerebrospinal fluid leakage, adopt clinically conventional reinforcement measures: autologous fat/fascia/muscle transplantation or supplementary interrupted suturing for leak blocking, without using any dural sealing adhesive products.
Recheck sealing effect intraoperatively by Valsalva maneuver / hemostatic sponge test, followed by postoperative routine drainage and identical follow-up schedule as the experimental group.
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After primary suture repair of spinal dural defect with intraoperative confirmed cerebrospinal fluid leakage, adopt conventional clinical reinforcement methods including autologous fat/fascia/muscle graft or supplementary suturing, without using any dural sealing adhesive products.
Intraoperative sealing verification and postoperative follow-up schedule are identical to the experimental group.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intraoperative Watertight Sealing Success Rate
Prazo: Intraoperatively (Visit 0)
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Proportion of subjects with no intraoperative CSF leakage confirmed by direct vision, Valsalva maneuver or hemostatic sponge test after assigned intervention.
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Intraoperatively (Visit 0)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Postoperative CSF Leakage Rate at Day 10±5
Prazo: Postoperative day 10±5 (Visit 1)
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Incidence of clinically confirmed CSF leakage via drainage fluid volume, MRI imaging or intracranial hypotension symptoms within 10±5 days post-surgery.
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Postoperative day 10±5 (Visit 1)
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Postoperative CSF Leakage Rate at Day 90±7
Prazo: Postoperative day 90±7 (Visit 2)
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Incidence of delayed CSF leakage, pseudomeningocele or wound CSF leakage confirmed by MRI or clinical manifestations within 90±7 days post-operation.
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Postoperative day 90±7 (Visit 2)
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Postoperative Drainage Volume and Drain Indwelling Duration
Prazo: Postoperative day 10±5 (Visit 1)
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Daily drainage fluid volume from surgical drain and total catheter retention time for patients with postoperative drainage tube placement.
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Postoperative day 10±5 (Visit 1)
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Incidence of All Adverse Events and Serious Adverse Events
Prazo: From surgery to postoperative day 90±7
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Overall occurrence rate of treatment-emergent adverse events and serious adverse events related or unrelated to the dural medical adhesive throughout the 90-day follow-up period.
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From surgery to postoperative day 90±7
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
29 de maio de 2024
Conclusão Primária (Real)
19 de junho de 2025
Conclusão do estudo (Real)
28 de julho de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
4 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de agosto de 2026
Primeira postagem (Real)
10 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- MP-CTP-YYJ2024
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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